BioCentury
ARTICLE | Regulation

FDA's quality crusade

FDA plans sea change in regulation of drug manufacturing quality, innovation

August 4, 2014 7:00 AM UTC

FDA believes the global pharmaceutical industry needs to modernize the way it makes drugs and active pharmaceutical ingredients. The agency plans to prod, cajole, and if necessary whack companies into changing the way they manufacture products, as well as their cultural assumptions about quality.

Industry investment in manufacturing technology and government investment in regulatory science to support improved manufacturing could reduce quality-related blowups that have derailed and delayed launches of new products, Janet Woodcock told BioCentury...